School of Environment, The University of Auckland, Auckland, New Zealand.
Metrology Research Centre, National Research Council Canada, Ottawa, Ontario, Canada.
Nat Nanotechnol. 2021 Sep;16(9):955-964. doi: 10.1038/s41565-021-00964-7. Epub 2021 Sep 13.
Nanopesticides are not only in an advanced state of research and development but have started to appear on the market. Industry and regulatory agencies need a consolidated and comprehensive framework and guidance for human health risk assessments. In this perspective we develop such a comprehensive framework by exploring two case studies from relevant product types: an active ingredient delivered with a nanocarrier system, and a nanoparticle as an active ingredient. For a nanocarrier system, three entities are tracked during the assessment: the nanocarrier-active ingredient complex, the empty nanocarrier remaining after the complete release of the active ingredient, and the released active ingredient. For the nanoparticle of pure active ingredient, only two entities are relevant: the nanoparticle and the released ions. We suggest important adaptations of the existing pesticide framework to determine the relevant nanopesticide entities and their concentrations for toxicity testing. Depending on the nature of the nanopesticides, additional data requirements, such as those pertaining to durability in biological media and potential for crossing biological barriers, have also been identified. Overall, our framework suggests a tiered approach for human health risk assessment, which is applicable for a range of nanopesticide products to support regulators and industry in making informed decisions on nanopesticide submissions. Brief summaries of suitable methods including references to existing standards (if available) have been included together with an analysis of current knowledge gaps. Our study is an important step towards a harmonized approach accepted by regulatory agencies for assessing nanopesticides.
纳米农药不仅处于研究和开发的高级阶段，而且已经开始出现在市场上。工业界和监管机构需要一个综合和全面的框架和指导，用于进行人类健康风险评估。从这个角度出发，我们通过探索两种相关产品类型的案例研究来开发这样一个综合框架：一种是通过纳米载体系统输送的活性成分，另一种是作为活性成分的纳米颗粒。对于纳米载体系统，在评估过程中跟踪三个实体：纳米载体-活性成分复合物、活性成分完全释放后剩余的空纳米载体以及释放的活性成分。对于纯活性成分的纳米颗粒，只有两个实体相关：纳米颗粒和释放的离子。我们建议对现有农药框架进行重要的调整，以确定相关纳米农药实体及其浓度，用于毒性测试。根据纳米农药的性质，还确定了其他数据要求，例如在生物介质中的耐久性和潜在的跨生物屏障能力。总体而言，我们的框架为人类健康风险评估提出了一种分层方法，适用于一系列纳米农药产品，以支持监管机构和行业在做出有关纳米农药提交的决策时做出明智的决策。本文包括了适合的方法的简要摘要，包括对现有标准（如果有的话）的引用，以及对当前知识差距的分析。我们的研究是朝着被监管机构接受的评估纳米农药的协调方法迈出的重要一步。
